da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE SCISSORS TIP/SLEEVE COVER FELL OFF INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2021. THE CHARGE NURSE REPORTED THEY SHE WAS NOT PRESENT DURING THE REPORTED ISSUE; HOWEVER, WAS CALLED INTO THE ROOM AFTER THE ISSUE OCCURRED AND ASSISTED THE STAFF. THE CHARGE NURSE INFORMED THAT THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THE INSTALLATION TOOL WAS USED AND NO ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE STAFF INFORMED THE CHARGE NURSE THAT DURING THE CASE, THEY HAD OBSERVED THE MCS TIP COVER ACCESSORY STARTING TO SLIDE OFF AND DECIDED TO REMOVE THE INSTRUMENT. HOWEVER, AT THE MOMENT THEY REMOVED THE INSTRUMENT THROUGH THE TROCAR, THE MCS TIP COVER ACCESSORY FELL OFF AND INTO THE PATIENT. IT WAS NOTED THE PROCEDURE HAD BEEN IN PROGRESS FOR ABOUT FIVE HOURS. IT WAS UNKNOWN IF ANY LUBRICANT WAS USED PRIOR TO THE MCS TIP COVER ACCE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF PLASTIC FROM A SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR AT THE SITE ON 09-AUG-2021 AND OBTAINED THE FOLLOWING INFORMATION: BOTH THE FRAGMENT AND THE INSTRUMENT WILL BE RETURNED TO ISI. THEY RETRIEVED THE FRAGMENT WITH A LAPAROSCOPIC INSTRUMENT. SHE ESTIMATED THE INSTRUMENT WAS IN USE FOR 2 MINUTES BEFORE IT BROKE. NO POST-OPERATIVE TESTS WERE PERFORMED AND THERE HAVE BEEN NO REPORTS OF ANY COMPLICATIONS TO THE PATIENT POST-PROCEDURE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT JUST FINISHED SEALING AND CUTTING TISSUE WHEN A PIECE OF PLASTIC FELL OFF THE SYNCROSEAL INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT OR WITH ANY HARD OBJECT. THE ROBOTICS COORDINATOR DID NOT WANT TO SHARE ANY PATIENT INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A ¿SMALL RIVET¿ FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE AND THE SURGEON DISCONTINUED USING THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ON 28-JULY-2021. THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT WAS USED FOR APPROXIMATELY 10 MINUTES. THE SURGEON WAS DISSECTING BY THE HIATUS WHEN THE INSTRUMENT BROKE. THE BROKEN FRAGMENT WAS RETRIEVED BY USING A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE RETRIEVED AND IT WAS CONFIRMED VISUALLY. NO POST-OPERATIVE TESTS WERE PERFORMED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A CUREUS JOURNAL ARTICLE TITLED, ¿USE OF BARIATRIC PORTS IN 4-ARM ROBOTIC PARTIAL NEPHRECTOMY: A COMPARATIVE STUDY WITH THE STANDARD 3-ARM TECHNIQUE¿ (EL-ASMAR, J. M., SEBAALY, R., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: "TWO PATIENTS REQUIRED POSTOPERATIVE SELECTIVE ARTERIAL EMBOLIZATION FOR POSTOPERATIVE BLEEDING/ HEMATOMA." ISI CONTACTED THE AUTHOR CORRESPONDENCE WHO CONFIRMED THAT THESE CASES WERE PERFORMED IN THEIR CENTER. THE AUTHOR CORRESPONDENCE INDICATED THAT NONE OF THE COMPLICATIONS IN QUESTION WERE DUE TO A SYSTEM MALFUNCTION AND "THESE OCCURRENCES ARE EXPECTED COMPLICATIONS AFTER PARTIAL NEPHRECTOMY AND ARE INHERENT TO THIS TYPE OF SURGERY WHATEVER THE APPROACH OPEN, LAPAROSCOPIC OR ROBOTIC."

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS IN USE FOR 30 MINUTES AND A FRAGMENT FROM THE TEFLON PAD WAS FOUND TO BE MISSING. THE CUSTOMER STATED THAT THE WHITE FRAGMENTS FELL INSIDE THE PATIENT WHEN ACTIVATING THE ENERGY. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR ABOUT 30 MINUTES AND BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. THE SURGEON BELIEVED THE WHITE PART OF THE TIP MELTED WHEN ENERGY WAS ACTIVATED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE)

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A PIECE OF THE WHITE MATERIAL, REPORTED TO BE ABOUT 0.5 MM WAS MISSING FROM INSIDE THE JAW OF THE SYNCHROSEAL. THE SURGEON REPORTEDLY DECIDED TO CONTINUE USING THE PRODUCT, AND FELT THAT SINCE THE MISSING PART WAS VERY SMALL THAT THEY WOULD NOT BE ABLE TO FIND THE MISSING PART. IT WAS UNKNOWN WHETHER THE MISSING FRAGMENT HAD FALLEN INSIDE THE PATIENT OR ELSEWHERE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 27-JULY-2021: IT WAS UNKNOWN IF ANY FRAGMENT FELL INSIDE THE PATIENT AND UNKNOWN IF ANY FRAGMENT WAS RETRIEVED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WAS PERFORMED TO CHECK FOR RETAINED FRAGMENTS. THE PROCEDURE HAD BEEN IN PROCESS FOR 4 HOURS AND THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR ABOUT 20 MINUTES. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS FOUND. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR. IT WAS UNKNO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROGRASP INSTRUMENT HAD A FRACTURED WIRE IN ITS CABLE SYSTEM. FDA SAFETY REPORT ID # (B)(4).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2021, THE SUBJECT (B)(6) UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH HANDSEWN COLO-ANAL ANASTOMOSIS USING THE DA VINCI SP SURGICAL SYSTEM WITH DIVERTING LOOP ILEOSTOMY. AFTER DOCKING THE SP ROBOT, A SECONDARY PORT FOR THE STAPLING DEVICE WAS UTILIZED IN THE RIGHT LOWER QUADRANT. IT WAS NOTED THAT THE PROCEDURE WAS SUBSTANTIALLY MORE DIFFICULT BECAUSE OF SIGNIFICANT DIFFICULTY WITH MOBILIZING AND IDENTIFYING ANATOMICAL STRUCTURES DUE TO THE ALTERED SURGICAL FIELD SECONDARY TO INFLAMMATION AND TISSUE FRIABILITY LIKELY DUE TO HIS PREVIOUS HEMATOLOGICAL MALIGNANCY AND CURRENT THERAPY. THE TUMOR WAS LOCATED WITHIN A FINGER BREADTH OF THE ANAL CANAL AND DISSECTION AROUND THIS TUMOR NECESSITATED HANDSEWN COLO-ANAL ANASTOMOSIS WHICH WAS DONE WITH A STANDARD MUCOSECTOMY. THE SPECIMEN WAS DELIVERED THROUGH THE ANAL CANAL AND THEN SEWN TO THE DESCENDING COLON WITH VICRYL SUTURES. THE ANASTOMOSIS WAS EVALUATED AND FOUND TO BE VIABLE. A SINGLE DRAIN WAS LEFT IN THE DEEP PELVIS. THE TERMINAL ILEUM WAS IDENTIFIED AND BROUGHT OUT OF THE ILEOSTOMY SITE. CLOSURE OF THE SITE WAS COMPLETED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SUBJECT 600-02 (HEREAFTER REFERRED TO AS THE SUBJECT) UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH THE DA VINCI SP SURGICAL SYSTEM ON (B)(6) 2021. ON (B)(6) 2021, THE SUBJECT MET ALL STUDY ELIGIBILITY CRITERIA AND SIGNED THE INFORMED CONSENT. THE SP SYSTEM WAS DOCKED AFTER CREATION OF THE SP PORT AND THE ILEOSTOMY PORT. ONCE THE RECTUM WAS TRANSECTED WITH THE LAPAROSCOPIC STAPLER, THE SPECIMEN WAS DELIVERED THROUGH THE WOUND PROTECTING DEVICE IN THE SP PORT. THIS WAS THEN RESECTED AND A PROLENE PURSE STRING WAS UTILIZED TO ENTER THE ANVIL INTO THE DESCENDING COLON. AFTER THIS WAS SECURED AND REPLACED BACK INTO THE ABDOMEN, THE ABDOMEN WAS REINSUFFLATED WITH THE SP ROBOTIC DEVICE AND THE ANASTOMOSIS WAS CREATED. PROCTOSCOPIC AND FINGER EXAMINATION OF THE ANASTOMOSIS REVEALED THIS TO BE INTACT. A SECTION OF THE TERMINAL ILEUM WAS IDENTIFIED NEAR THE CECUM FOR THE DIVERTING LOOP ILEOSTOMY WHICH WAS PULLED THROUGH THE ILEOSTOMY SITE. THE SP PORT WAS REMOVED, THE SITE WAS THEN CLOSED, NO DRAINS WERE PLACED. THE ILEOSTOMY WAS THEN CREATED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERSION TO OPEN SURGERY, ROBOTIC MULTIPORT OR LAPAROS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. ON 15-JULY-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) CLARIFIED THAT THE PROMPT INDICATING EXCESS PRESSURE ON THE HARMONIC ACE INSTRUMENT DISPLAYED AFTER ONE HOUR, DURING THE PROCEDURE. THERE WAS NO ALLEGATION THAT THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. THE BLEEDING WAS COMING FROM THE LIVER TISSUE. THERE WAS APPROXIMATELY LESS THAN 800ML OF BLOOD LOSS. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF THE BLEEDING. THE CUSTOMER HAD TO ADMINISTER OR TRANSFUSE 400ML OF BLOOD. NO INFORMATION WAS PROVIDED REGARDING IF THE PATIENT HAD RETURNED TO THE HOSPITAL DUE TO POST

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON FOUND THE MONOPOLAR SCISSOR TIP WAS MISSING. THE CALLER FORWARDED A PICTURE SHOWING THAT THE TIP AND THE COUPLER WERE MISSING FROM THE MONOPOLAR SCISSOR. AT THE TIME OF THE CALL THE STAFF WAS UNABLE TO LOCATE THE COUPLER. THE STAFF REPLACED THE MONOPOLAR SCISSOR TIP AND WERE PROCEEDING WITH THE PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICES ENGINEER (TSE) EXPLAINED THE COUPLER IS RADIOLUCENT. THE REPORTER EXPLAINED SHE WOULD FOLLOW UP WITH ANY FURTHER DETAILS AS SHE RECEIVED THEM. THE TSE RECOMMENDED THE STAFF RMA THE MISSING MONOPOLAR SCISSOR TIP FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION ON 01-JULY-2021: THIS WAS A MONOPOLAR SCISSOR TIP SINGLE PORT (SP) INSTRUMENT SO IT WAS THE PLASTIC PORTION THAT GOES OVER THE SCREWS AND THE ACTUAL TIP THAT FELL IN THE PATIENT. THE PIECES WAS RETRIEVED AT THE END OF THE PROCEDURE. WE HAVE REQUESTED TO SEND BACK THE INSTRUMENT AND THE BROKEN PIECES BACK TO ISI. SHE WAS NOT IN THE PROCEDURE, BUT SAID THE ROBOTICS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I HAD WHAT WAS SUPPOSED TO BE A ROUTINE GALLBLADDER REMOVAL. I SPENT THREE DAYS IN AN (B)(6) HOSPITAL, WENT HOME FOR TWO DAYS, AND SPENT AN ADDITIONAL TWO DAYS IN ANOTHER (B)(6) HOSPITAL. I EXPERIENCED BLEEDING AT A WOUND SITE (POST-SURGERY) THAT REQUIRED THREE BLOODIED DRESSING CHANGES AND SUTURING AT THE BLEEDING WOUND SITE. I WAS RELEASED FOR THE FIRST HOSPITAL, WITH A FOLEY BAG THAT WAS INSERTED ON FOUR DIFFERENT OCCASIONS, BUT NEVER SAW A UROLOGIST IN THE HOSPITAL. THE DAY AFTER DISCHARGE, I BEGAN TO BLEED, ONCE AGAIN, AT THE SUTURED WOUND SITE. I WENT TO THE LOCAL (B)(6) EMERGENCY TO HAVE THE WOUND CLEANED AND REDRESSED. TWO DAYS LATER, I CALLED A UROLOGY OFFICE NOTED IN MY DISCHARGE INSTRUCTIONS AND WAS TOLD THEY COULD NOT SEE ME FOR TWO WEEKS. I WENT BACK TO THE LOCAL (B)(6) EMERGENCY ROOM TO HAVE THE CATHETER REMOVED. THEY PERFORMED ADDITIONAL TESTS AND SAID I WAS BLEEDING INTERNALLY AND HAD POCKETS OF BLOOD IN THREE LOCATIONS IN MY ABDOMEN AND RUSHED ME TO A DIFFERENT (B)(6). A PHYSICIAN, WHO IDENTIFIED HIMSELF AS PART OF THE SURGICAL TEAM, SAID HE WANTED ME TO STAY IN THE HOSPITAL, OVERNIGHT, TO MONITOR MY HEMOGLOBIN LEVEL. I ASKED THE "SURGICAL TEAM" PHYSICIAN TO ARRANG

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF THE MCS INSTRUMENT. IT WAS NOTED THAT THEY "FLIPPED BETWEEN ROBOT TO OPEN TO LAP SEVERAL TIMES" FOR THE PROCEDURE AND THAT DURING ONE OF THE TRANSITIONS THEY NOTICED THAT THE MCS TIP COVER ACCESSORY WAS MISSING. THE CUSTOMER WAS ASKING IF THE ITEM WAS DETECTABLE VIA X-RAY OR CT SCAN. THE CUSTOMER LATER FOLLOWED UP TO LET US KNOW THAT THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, AND THAT THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP ON 21-JUNE-2021. THE CUSTOMER WAS UNABLE TO SPECIFY AT WHAT POINT THE MCS TIP COVER ACCESSORY HAD FALLEN OFF OF THE INSTRUMENT. NO FURTHER DETAILS WERE AVAILABLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT, "MOST RECENTLY WAS AN ISSUE WITH THE NEW SYNCHROSEAL INSTRUMENT, PATIENT SAFETY CONCERN WITH BROKEN PIECE." THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. CUSTOMER FEEDBACK RELATED TO AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT WAS RECEIVED VIA A BLIND SURVEY. ISI IS UNABLE TO PERFORM FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION DUE TO THE NATURE OF HOW THIS INFORMATION WAS COLLECTED. NO PRODUCT, REPORTER, OR SITE INFORMATION WAS AVAILABLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RIGHT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT DEVELOPED A POSTOPERATIVE CHYLOTHORAX. THE SURGEON COMMENTED THAT THE SEALING OF THE SYNCHROSEAL MAY BE UNSATISFACTORY. THE PATIENT WAS HOSPITALIZED AND UNDER OBSERVATION. IT IS UNKNOWN IF ANY MEDICAL/SURGICAL INTERVENTION WAS TAKEN. THE PROCEDURE WAS COMPLETED AS PLANNED. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR), WHO SPOKE TO THE CUSTOMER, AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM, INSTRUMENT AND ACCESSORY WERE INSPECTED BEFORE USE AND THERE WAS NOTHING OUT OF THE ORDINARY. THERE WAS NO MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT OR ACCESSORY THAT OCCURRED. THERE WAS NO EVIDENCE OF INSUFFICIENT SEALING/CAUTERY ISSUE/INTRA-OPERATIVE COMPLICATION OBSERVED DURING THE PROCEDURE AND THE SURGERY WAS COMPLETED AS PLANNED. THERE WAS NO UNEXPECTED BLEEDING OBSERVED DURING THE PROCEDURE. THE CUSTOMER CONFIRMED THAT THE TISSUE BUNDLE WAS LESS THAN 5 MM, THE TISSUE FIT IN THE JAWS OF THE INSTRUMENT, THERE WAS NO TISSUE TENSION, NO CONTACT WITH HARD MATERIAL, NO EVIDENCE OF VESSEL CALCIFICATION AND THE INSTRUMENT JAWS WERE NOT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS FOUND TO HAVE A MELTED TEFLON PAD. FRAGMENTS FROM THE INSTRUMENT REPORTEDLY FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION AND WERE "VERY HARD TO BE RETRIEVED." THE SURGEON RETRIEVED THE FRAGMENTS WITH A BACKUP INSTRUMENT AND NOTED CONCERN ABOUT THE QUALITY OF THE TEFLON PAD. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. THE FRAGMENTS ARE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE IDENTIFIED. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 10 TO 20 MINUTES BEFORE THE ISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. THE REPORTER NOTED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS AS WAS INITIALLY REPORTED. THERE WAS NO PATIENT INJURY

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿SALVAGE VERSUS PRIMARY ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY-MATCHED COMPARATIVE EFFECTIVENESS STUDY FROM A HIGH-VOLUME TERTIARY CENTRE¿ (NATHAN, A., FRICKER, M., ET AL., 2021). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS CITED -ONE PATIENT SUFFERED FROM A HEMATOMA REQUIRING REOPERATION AND WASHOUT AFTER HIFU THERAPY. ON 15-JUN-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT THE DURING PORT INCISION, THERE WAS A VESSEL (VEIN) INJURY. AS A RESULT, THE PATIENT EXPERIENCED A HEMATOMA. THE ESTIMATED BLOOD LOSS INTRA-OPERATIVELY WAS 250-500MLS. THERE WAS PROCEDURE FOR A WASHOUT AND HEMOSTASIS. THERE WAS NO BLOOD TRANSFUSION ADMINISTERED TO THE PATIENT. THE SURGEON HAD CONFIRMED THERE WAS NO RELATION TO THE DA VINCI PRODUCT. HOWEVER, IT IS UNKNOWN IF THE TROCAR WAS AN ISI PRODUCT OR A THIRD-PARTY PRODUCT. AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE IS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND REQUIRED HOSPITALIZATION IN THE ICU. THE SURGEON SAID HE NO LONGER WILL USE THE SYNCHROSEAL INSTRUMENT. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PROCEDURE OCCURRED IN JUNE BUT THE EXACT DATE WAS NOT PROVIDED. THE PROCEDURE WAS PERFORMED ON A DA VINCI SI SYSTEM WITH AN UNKNOWN SERIAL NUMBER. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL FOUND. THE SURGEON REPORTED THAT THE SYNCHROSEAL INSTRUMENT WORKED FINE AND NO ERRORS WERE GENERATED FOR THE INSTRUMENT. THE TARGET ISSUE WAS THE PROSTATE PEDICLE. THE TARGET TISSUE WAS REPORTEDLY UNDER TENSION DURING THE SEALING AND CUTTING PROCESS. THE TARGET TISSUE WAS NOT A VESSEL GREATER THAN 5MM, HAD NO CALCIFICATION, AND NO PREVIOUS RADIATION OR CHEMOTHERAPY. THE SURGEON REPORTED THAT THEY OBSERVED TISSUE EFFECT DURING THE SEALING/SYNCH CYCLE. THE SURGEON SAID THE SYNCHROSEAL INSTRUMENT NEVER CAME INTO CONTACT WITH METAL OBJECTS SUCH AS STAPLES, SUTURES, AND CLIPS DURING THE PROCEDURE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿SALVAGE VERSUS PRIMARY ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY-MATCHED COMPARATIVE EFFECTIVENESS STUDY FROM A HIGH-VOLUME TERTIARY CENTRE¿ (NATHAN, A., FRICKER, M., ET AL., 2021). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS CITED -ONE PATIENT SUFFERED FROM RECTAL INJURY WITH INTRAOPERATIVE PRIMARY REPAIR FOLLOWING WHOLE GLAND RADIOTHERAPY. ISI HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO THE REACH OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT. AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE IS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT. MOREOVER, THERE IS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THAT AN INTUITIVE PRODUCT CAUSED OR CONTRIBUTED TO THE OPERATIVE COMPLICATION REFERENCED IN THE ARTICLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 22-NOV-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A INTERNATIONAL JOURNAL OF UROLOGY CASE REPORTS ARTICLE TITLED, ¿ENDOSCOPIC LASER TREATMENT FOR URINE LEAKAGE CAUSED BY AN ISOLATED CALYX AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY¿ (INOUE, R., ISOYAMA, N., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, A POST-OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: "AN (B)(6) MAN UNDERWENT ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR THE TREATMENT OF RENAL CELL CARCINOMA (CT1BN0M0). POSTOPERATIVELY, URINE LEAKAGE WAS OBSERVED AND DID NOT IMPROVE WITH CONSERVATIVE MEASURES. RETROGRADE PYELOGRAPHY AND COMPUTED TOMOGRAPHY REVEALED THAT URINE LEAKAGE ORIGINATED FROM THE ISOLATED CALYX CAUSED BY INFUNDIBULAR STENOSIS. ENDOSCOPIC TREATMENT VIA THE TRANSURETHRAL APPROACH WAS SELECTED TO PRESERVE RENAL FUNCTION. URETEROSCOPY SHOWED THAT THE UPPER CALYX WAS COMPLETELY OBSTRUCTED BY THE SUTURES. THEREFORE, WE CUT THE SUTURE THREAD USING LASER, AND A URETERAL STENT WAS PLACED IN THE UPPER RENAL CALYX. FLUID DRAINAGE IMMEDIATELY DISAPPEARED AFTER THE PROCEDURE, AND THE PATIENT DID NOT LOSE RENAL FUNCTION." ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, PIECES FROM THE CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE ALL FRAGMENTS DURING THE SAME PROCEDURE. THE CANNULA SEAL IS AVAILABLE FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION; HOWEVER, THE FRAGMENTS ARE NOT ABLE TO BE RETURNED. THE CUSTOMER REPLACED THE CANNULA SEAL WITH A BACK-UP ACCESSORY OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND REQUIRED HOSPITALIZATION IN THE ICU. THE SURGEON SAID HE NO LONGER WILL USE THE SYNCHROSEAL INSTRUMENT. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PROCEDURE OCCURRED IN JUNE BUT THE EXACT DATE WAS NOT PROVIDED. THE PROCEDURE WAS PERFORMED ON A DA VINCI SI SYSTEM WITH AN UNKNOWN SERIAL NUMBER. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL FOUND. THE SURGEON REPORTED THAT THE SYNCHROSEAL INSTRUMENT WORKED FINE AND NO ERRORS WERE GENERATED FOR THE INSTRUMENT. THE TARGET ISSUE WAS THE PROSTATE PEDICLE. THE TARGET TISSUE WAS REPORTEDLY UNDER TENSION DURING THE SEALING AND CUTTING PROCESS. THE TARGET TISSUE WAS NOT A VESSEL GREATER THAN 5MM, HAD NO CALCIFICATION, AND NO PREVIOUS RADIATION OR CHEMOTHERAPY. THE SURGEON REPORTED THAT THEY OBSERVED TISSUE EFFECT DURING THE SEALING/SYNCH CYCLE. THE SURGEON SAID THE SYNCHROSEAL INSTRUMENT NEVER CAME INTO CONTACT WITH METAL OBJECTS SUCH AS STAPLES, SUTURES, AND CLIPS DURING THE PROCEDURE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OF THE MCS INSTRUMENT AND FELL INTO THE PATIENT. THE MCS TIP COVER ACCESSORY WAS REMOVED FROM THE PATIENT AND WAS REPORTEDLY DISCARDED. THE PROCEDURE WAS COMPLETED USING A BACKUP MCS TIP COVER ACCESSORY WITH NO REPORTED INJURY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) PROVIDED THE FOLLOWING INFORMATION: THE OPERATING ROOM NURSE WHO REPORTED THIS ISSUE TO THE CTA STATED SHE DOES NOT HAVE THE EVENT DATE INFORMATION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. INSTALLATION OF TIP COVER ACCESSORY ON THE MCS INSTRUMENT WAS "EASIER THAN NORMAL." THE MCS TIP COVER ACCESSORY FELL INTO THE ABDOMEN AND THEY RETRIEVED IT WITH THE REMAINING INSTRUMENTS. INSTRUMENT REMOVAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE NURSE TOLD THE CTA THAT THE MCS TIP COVER ACCESSORY AND THE MCS WERE NOT BEEN DAMAGED. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. NO ELECTROLUBE OR OTHER LUBRICANT APPLIED TO THE MCS INSTRUMENT PR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE WAS SUDDENLY BROKEN. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS USED FOR ABOUT ONE HOUR AND THE INSTRUMENT BLADE WAS BROKEN INSIDE THE PATIENT. THE SURGEON REMOVED THE FRAGMENT BY USING A GRASPER, DURING THE SAME PROCEDURE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE FOUND. DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE INSTRUMENT BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED UPON VISUAL INSPECTION. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THERE WAS NO PATIENT INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, A SMALL DISC FELL OFF OF THE SYNCHROSEAL INSTRUMENT AND INTO THE ABDOMEN OF THE PATIENT. THE SMALL DISC WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON (B)(6) 2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED VIA ROBOTIC INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND WAS UNSURE OF THE CAUSE OF THE ISSUE. THE FOLLOWING WAS INFORMATION WAS REQUESTED, BUT WAS UNKNOWN: WHAT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE ISSUE, HOW LONG THE INSTRUMENT HAD BEEN IN USE AT THE TIME OF THE ISSUE, IF THERE WERE ANY COLLISIONS, IF THE INSTRUMENT WAS REMOVED THROUGH THE CANNULA PRIOR TO THE ISSUE, AND IF THERE WAS ANY OTHER DAMAGE TO THE INSTRUMENT OR THE CANNULA ONCE THE INSTRUMENT HAD BEEN REMOVED. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI. THERE ARE PHOTOGRAPHIC IMAGES AVAILABLE OF THE INSTRUMENT AND THE FRAGMENT. PATIENT-RE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THERE WAS NO REPORT OF ANY FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THERE WAS NO REPORT OF ANY FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE USER OBSERVED THAT "THE PART THAT HOLDS THE SYNCHROSEAL INSTRUMENT JAW COVER WAS DAMAGED" AND A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE USER NOTED THAT THE INSTRUMENT WAS NOT INVOLVED IN ANY KNOWN INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED AND REPLACED TO THE BACKUP. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND FOUND NO ISSUE. INSTRUMENT OPERATED WITH NO FUNCTIONAL ISSUE. SURGEON ALLEGES NO INCIDENT OF INSTRUMENT COLLISION. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY AN HOUR. THE FALLEN FRAGMENT WAS REMOVED THROUGH THE ASSIST PORT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. STANDARD POST-OPERATIVE TESTS WERE PERFORMED AND CONFIRMED NO RETAINED FRAGMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DA VINCI XI ROBOT EXPERIENCED NONRECOVERABLE FAULT ERROR CODE 307 DURING MID PROCEDURE. INSTRUMENT ARMS WERE LEFT IN PATIENT. REP ADVISED TOTAL SYSTEM SHUTDOWN AND RESTART. SYSTEM SHUT DOWN AND RESTARTED 3 TIMES, NONRECOVERABLE FAULT RESULTED EACH TIME. INSTRUMENTS AND DA VINCI REMOVED MANUALLY AS RESULT OF FAILURE. PROCEDURE CONTINUED THORACOSCOPICALLY. AFTER TROUBLESHOOTING THIS ISSUE, DA VINCI REP DETERMINED THE TITLE PRO CABLE CONNECTED TO THE STORZ CAMERA SYSTEM FRIED THE TITLE PRO INPUT BOX IN THE DA VINCI ROBOT, RESULTING IN NONRECOVERABLE FAULT ERROR CODE 307. VENDOR CAME ONSITE 5/16 AND REPAIRED UNIT. UNIT RETURNED TO SERVICE. VIDEO OUTPUT ON VISION TOWER WAS REPLACED. COMPOSITE VIDEO COMPONENT PROTRUDES FROM EQUIPMENT LEADING TO HIGHER LIKELIHOOD OF DAMAGE. FDA SAFETY REPORT ID # (B)(4).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA-PARAESOPHAGEAL SURGICAL PROCEDURE, PART OF THE SHEAR OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED FROM THE ABDOMEN. THE CUSTOMER OPENED ANOTHER HARMONIC ACE INSTRUMENT TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATECTOMY SURGICAL PROCEDURE, A PLASTIC PART FROM THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND A BACKUP INSTRUMENT WAS USED TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER RETRIEVED FRAGMENTS AND CONFIRMED BY VISUAL INSPECTION THAT ALL BROKEN PIECES WERE RETRIEVED. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENTS. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE FOR LESS THAN 1 HOUR PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE SURGEON WAS REMOVING THE INSTRUMENT WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE EVENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE FINAL REMOVA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED AND NO PARTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT REGARDING THIS EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY FELL INTO THE SITUS. THE TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO FOLLOW-UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS RELATED TO THE EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE THE SYNCHROSEAL INSTRUMENT JAW HINGE PIN, END PIECE, FELL OFF THE INSTRUMENT INTO THE PATIENT. THE SURGEON RETRIEVED THE PIECE WITH A BACKUP INSTRUMENT AND CONTINUED THE PROCEDURE. NO OTHER PIECES WERE OBSERVED TO BE MISSING FROM THE INSTRUMENT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CALLER TO PROMPT THE CUSTOMER TO RETURN THE INSTRUMENT FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT ONE OF THE PADS ON THE HARMONIC SCALPEL FELL OFF INTO THE PATIENT. THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THE ISSUE HAD OCCURRED AND THE CUSTOMER RETRIEVED THE GREY INSTRUMENT TIP PAD WITH NO ISSUES TO THE PATIENT. IT WAS NOTED THE CUSTOMER DISCARDED THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CLINICIAN INFORMED THE INSTRUMENT WAS INSPECTED PRIOR TO USE. PRIOR TO THE FRAGMENT FALLING, THE INSTRUMENT HAD BEEN IN USE FOR ABOUT 45  60 MINUTES. AT THE TIME OF THE REPORTED ISSUE, THE CLINICIAN NOTED THAT THE SURGEON WAS PERFORMING AN EXCISION OF FIBROIDS AND STATED THE HARMONIC INSTRUMENT AND TENACULUM INSTRUMENT COLLIDED. THE SURGEON DID NOT NOTICE AN ISSUE WITH THE INSTRUMENT FUNCTIONALITY DURING THE CASE. IT WAS NOTED THE FRAGMENT FELL OFF INTO THE PATIENT IN THE MIDDLE OF THE CASE AND DID NOT OCCUR DURING AN INSTRUMENT COLLISION. THE WHITE TIP OF THE HARMONIC INSTRUMENT WAS RETRIEVED IN ONE PIECE WITH A G

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS FOUND TO HAVE THE BUTTON FELL OFF. THE BUTTON WAS IN A CUP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE BUTTON SIMPLY FELL OFF AND WAS DISCOVERED WITHIN THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE FRAGMENT WAS LIKELY RETRIEVED WITH A ROBOTIC/LAP INSTRUMENT DURING THE CASE. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT NOR ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE WRIST WAS NOT STRAIGHTENED PRIOR TO REMOVAL BUT WAS STRAIGHTENED UPON FINAL REMOVAL OF THE INSTRUMENT. NO PATIENT INJURY WAS IDENTIFIED. THE PART L90200818-0262 WAS USED ON (B)(6) 2021.